Novii+ Wireless Maternal and Fetal Monitoring Solution Cleared by the FDA for Monitoring Approximately 95% of All Eligible Births in the United States¹

Rhea-AI Summary

GE HealthCare has received FDA clearance for an expanded indication for Novii+ maternal and fetal monitoring solution for pregnant patients ≥34 weeks. The Novii+ noninvasively measures and displays fetal heart rate, maternal heart rate, and uterine activity, providing patient comfort and mobility in the hospital. The wireless design enables mobility and freedom for mothers, and studies have shown that it may help decrease the length of labor. Novii+ is an expanded indication from the Novii Maternal and Fetal Monitoring Solution that utilizes an updated algorithm to improve reliability and accuracy. It can be used for both antepartum and intrapartum pregnant patients 34 weeks and greater, which extends usage before the previously defined use of 37 weeks and greater of pregnancy. The expanded indication is based on data submitted to the FDA to determine Novii+ Wireless Patch Solution’s equivalence to doppler fetal heart rate, tocodynamometer uterine activity, and pulse oximetry maternal heart rate devices for preterm patients (≥34 weeks) in terms of accuracy and reliability. It is a first-of-its-kind patch-based antepartum and intrapartum monitoring solution for preterm patients (≥34 weeks). The Novii+ Wireless Patch Solution will be available to customers in the United States later this year.

Insights

Medical Research Analyst

The recent FDA clearance of GE HealthCare's Novii+ Wireless Patch Solution for use in pregnant patients at 34 weeks and above represents a significant advancement in maternal and fetal monitoring technology. The expanded indication allows for earlier intervention in high-risk pregnancies, potentially improving outcomes for both mothers and infants. This decision is based on robust data that indicates Novii+ is equivalent to traditional monitoring methods like doppler fetal heart rate, tocodynamometer and pulse oximetry devices in terms of accuracy and reliability.

From a research perspective, the introduction of a wireless, patch-based system like Novii+ may lead to increased adoption rates within healthcare facilities due to the enhanced patient comfort and mobility it offers. Studies have suggested that mobility during labor can reduce its duration, which could, in turn, decrease hospital labor costs and improve bed turnover rates. However, the long-term impact on clinical outcomes and cost-effectiveness of this technology requires further investigation.

Healthcare Economist

The economic implications of the FDA's clearance for Novii+ are multifaceted. On one hand, the use of Novii+ could streamline the labor and delivery process, offering potential cost savings for healthcare providers. The wireless nature of the device may reduce the need for multiple monitoring devices and allow for better resource allocation within maternity wards. On the other hand, the upfront costs of adopting new technologies like Novii+ might be a barrier for some institutions, especially those already under financial strain.

Moreover, the ability of Novii+ to improve monitoring for preterm and high-risk pregnancies could lead to a reduction in long-term healthcare costs by preventing complications that require expensive treatments or extended hospital stays. However, the actual economic impact will depend on the device's price point, reimbursement policies and the scale of its adoption.

Market Research Analyst

GE HealthCare's Novii+ Wireless Patch Solution enters a competitive market of maternal and fetal monitoring devices, but its unique features such as belt-free mobility and the Cross Check artifact reduction algorithm distinguish it from other products. The market for such devices is growing, driven by an increased focus on maternal health and technological innovation.

Considering that one in ten newborns in the United States is born prematurely, the extended indication for Novii+ to cover pregnancies from 34 weeks could capture a significant market share. The device's real-time monitoring capabilities and integration with hospital systems may also appeal to healthcare providers looking to enhance patient care and safety. However, the product's success will hinge on factors like healthcare provider training, integration with existing hospital infrastructure and patient acceptance of the new technology.

• GE HealthCare receives FDA clearance for expanded indication for Novii+ maternal and fetal monitoring solution for pregnant patients ≥34 weeks.
• Novii+ noninvasively measures and displays fetal heart rate, maternal heart rate and uterine activity, while providing patient comfort and mobility in the hospital.

CHICAGO--(BUSINESS WIRE)-- GE HealthCare (Nasdaq: GEHC) today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for Novii™+ Wireless Patch Solution. The antepartum and intrapartum maternal and fetal monitor noninvasively measures and displays fetal heart rate, maternal heart rate and uterine activity, so care teams can have a real-time view of patient data. Through its belt-free and wireless design, Novii+ enables mobility and freedom for mothers to support the laboring experience. Additionally, studies have shown upright positions and walking may help decrease the length of labor.²

“Novii+ allows moms to move around and stay active during labor while providing reliable monitoring for their care teams,” said Lisa Allen, BSN, RN, senior clinical development specialist, maternal infant care, GE HealthCare. “This freedom of movement can help moms have a more comfortable labor experience.”

Novii+ is an expanded indication from the Novii Maternal and Fetal Monitoring Solution that utilizes an updated algorithm (Cross Check artifact reduction) to improve reliability and accuracy. Novii+ can be used for both antepartum and intrapartum pregnant patients 34 weeks and greater, which extends usage before the previously defined use of 37 weeks and greater of pregnancy. The expanded indication is based on data submitted to the FDA to determine Novii+ Wireless Patch Solution’s equivalence to doppler fetal heart rate, tocodynamometer uterine activity and pulse oximetry maternal heart rate devices for preterm patients (≥34 weeks) in terms of accuracy and reliability. In the United States, Novii+ is a first-of-its-kind patch-based antepartum and intrapartum monitoring solution for preterm patients (≥34 weeks).

Monitoring is crucial to check on health status for both pregnant patients and their fetuses particularly for preterm and high-risk pregnancies.³ Novii+ provides a personalized view of the mother and fetus’ statuses, and alerts care teams for changes to heart rate and contraction pattern during labor, so they can proactively intervene.

“One in ten newborns in the United States is born prematurely, a rate that has not changed significantly in over 60 years.⁴ At the same time, maternal morbidity and mortality have increased, especially for women of color,”⁵ said Kurt R. Wharton, MD, FACOG, a professor and obstetrician-gynecologist.¹ ”New technologies and approaches are crucially needed to improve maternal and newborn outcomes. With the expanded indication for Novii+, care teams can now use the fetal and maternal monitoring solution for a larger number of patients faced with high-risk pregnancies,“ adds Wharton.

_____________________________

1 Dr. Kurt R. Wharton is a paid consultant for GE HealthCare. The statements by Dr. Wharton described here are based on his own opinions and on results that were achieved in his unique setting. Since there is no “typical” hospital and many variables exist, i.e. hospital size, case mix, etc., there can be no guarantee that other customers will achieve the same results.

Intrapartum monitoring provides care teams with the data needed to care for their patients confidently and efficiently.³ Nearly all respondents (97%) of GE HealthCare’s The State of Flexible Healthcare Delivery survey reported visual dashboards for monitoring patient status is moderately or critically important. By connecting to other monitors in the hospital, Novii+ allows data to flow seamlessly to existing surveillance and archival systems. The Novii+ Wireless Patch Solution will be available to customers in the United States later this year.

GE HealthCare designs solutions to meet the needs of providers, families, and patients to support care that can help send moms and babies home healthy. For more information on our fetal and maternal monitoring solutions, please visit: https://www.gehealthcare.com/products/maternal-infant-care/fetal-monitors

ABOUT GE HEALTHCARE TECHNOLOGIES INC.

GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 100 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from prevention and screening, to diagnosis, treatment, therapy, and monitoring. We are an $18 billion business with 50,000 employees working to create a world where healthcare has no limits.

Follow us on Facebook, LinkedIn, Twitter, Instagram and Insights for the latest news, or visit our website www.gehealthcare.com for more information.

___________________________

1Natality, 2016-2022 expanded Request. Centers for Disease Control and Prevention. Group By: Plurality; OE Gestational Age Weekly. Accessed January 31, 2024. https://wonder.cdc.gov/natality-expanded-current.html

2Lawrence A, Lewis L, Hofmeyr GJ, Dowswell T, Styles C. Maternal positions and mobility during first stage labour. Cochrane Database Syst Rev. 2009 Apr 15 ; (2) : CD003934

3Ayres-de-Campos, D., Spong, C.Y., Chandraharan, E. and (2015), FIGO consensus guidelines on intrapartum fetal monitoring: Cardiotocography. International Journal of Gynecology & Obstetrics, 131: 13-24. https://doi.org/10.1016/j.ijgo.2015.06.020

4Preterm birth. Centers for Disease Control and Prevention. October 24, 2023. Accessed December 29, 2023. https://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm

5Hoyert D. Maternal Mortality Rates in the United States, 2021. www.cdc.gov. Published March 16, 2023. https://www.cdc.gov/nchs/data/hestat/maternal-mortality/2021/maternal-mortality-rates-2021.htm

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240201621167/en/

GE HealthCare Media Contact:

Jennifer Purdue

M +1 267 593 9735

jennifer.purdue@gehealthcare.com

Source: GE HealthCare

FAQ

What is the expanded indication for Novii+ maternal and fetal monitoring solution?

The expanded indication allows the use of Novii+ for both antepartum and intrapartum pregnant patients 34 weeks and greater, extending usage before the previously defined use of 37 weeks and greater of pregnancy.

What are the main features of Novii+?

Novii+ noninvasively measures and displays fetal heart rate, maternal heart rate, and uterine activity, providing patient comfort and mobility in the hospital. It utilizes an updated algorithm to improve reliability and accuracy.

What is the significance of the Novii+ Wireless Patch Solution?

It is a first-of-its-kind patch-based antepartum and intrapartum monitoring solution for preterm patients (≥34 weeks), providing a personalized view of the mother and fetus’ statuses and alerts care teams for changes to heart rate and contraction pattern during labor.

When will the Novii+ Wireless Patch Solution be available to customers in the United States?

It will be available to customers in the United States later this year.

How does Novii+ contribute to improved maternal and newborn outcomes?

The expanded indication allows care teams to use the fetal and maternal monitoring solution for a larger number of patients faced with high-risk pregnancies, helping to improve maternal and newborn outcomes.

What is the aim of the Novii+ Wireless Patch Solution?

The aim is to provide care teams with the data needed to care for their patients confidently and efficiently, allowing data to flow seamlessly to existing surveillance and archival systems.

What are the benefits of the wireless design of Novii+?

The wireless design enables mobility and freedom for mothers to support the laboring experience, allowing moms to move around and stay active during labor while providing reliable monitoring for their care teams.

Where can I find more information about GE HealthCare's fetal and maternal monitoring solutions?

For more information, you can visit: https://www.gehealthcare.com/products/maternal-infant-care/fetal-monitors